Comparison of the Efficacy and Safety of Two Different Dose Adjustment Regimens for Insulin Degludec/Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Previously Treated With Insulin Glargine (BOOST®)
Status and phase
Completed
Phase 3
Conditions
Diabetes
Diabetes Mellitus, Type 2
Treatments
Drug: insulin degludec/insulin aspart
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
This trial is conducted in Africa, Asia, Europe and the United States of America (USA).
The aim of the trial is to compare the efficacy and safety of two different titration algorithms for insulin degludec/insulin aspart (IDeg/IAsp) in subjects with type 2 diabetes mellitus previously treated with insulin glargine.
Enrollment
272 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Type 2 diabetes (diagnosed clinically) for at least 24 weeks prior to Visit 2 (randomisation)
- Currently treated with IGlar (Insulin Glargine) and up to 3 oral antidiabetic drugs (OADs) (metformin, DPP-4 inhibitor, sulphonylurea/glinide or alpha-glucosidase inhibitor). All antidiabetic treatments should have been ongoing for at least 12 weeks prior to Visit 2 (randomisation) and doses should have been stable in this period of time
- Glycosylated haemoglobin (HbA1c) 7.0-10.0% (both inclusive) by central laboratory analysis
- Body mass index (BMI) below or equal to 40 kg/m^2
Exclusion criteria
- Treatment with glucagon-like peptide 1 (GLP-1) receptor agonists or thiazolidinediones (TZDs) both within the last 12 weeks prior to Visit 2 (randomisation)
- Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; all within the last 24 weeks prior to Visit 2 (randomisation)
- Uncontrolled or untreated severe hypertension defined as systolic blood pressure above or equal to 180 mmHg and/or diastolic blood pressure above or equal to 100 mmHg
- Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during last 12 months) or hypoglycaemic unawareness as judged by the investigator
- Life-threatening disease (e.g. cancer)
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
272 participants in 2 patient groups
IDegAsp Simple
Experimental group
Treatment:
Drug: insulin degludec/insulin aspart
Drug: insulin degludec/insulin aspart
IDegAsp Step wise
Experimental group
Treatment:
Drug: insulin degludec/insulin aspart
Drug: insulin degludec/insulin aspart
Trial contacts and locations
45
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Data sourced from clinicaltrials.gov
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